IPBiz

Friday, June 30, 2017

D. Delaware finds Enzo's US 6,992,180 invalid for lack of enablement

Genomeweb on 29 June 2017 posted:

Enzo Biochem said today [June 29] that one of its patents at the center of a long-running intellectual property dispute has been found invalid by a federal judge.

US Patent No. 6,992,180 relates to modified nucleotides for use in diagnostic and therapeutic applications. The patent is assigned to Enzo and is central to separate ongoing lawsuits between Enzo and Hologic, Gen-Probe (now part of Hologic), Roche Molecular Systems, and Becton Dickinson.

Enzo originally sued these companies and several others for allegedly infringing the '180 and other related patents. A handful of defendants settled with Enzo in recent years, while others sought to have Enzo's patents invalidated.

Enzo said today that the US District Court for the District of Delaware has granted summary judgment for the aforementioned defendants that the '180 patent is invalid for lack of enablement. However, the court also denied summary judgment that the patent is invalid for lack of written description.

Writing in 2017 U.S. Dist. LEXIS 101652, Judge Stark observed in an opinion filed on 28 June 2017:

To comply with the written description requirement, a patent's specification "must clearly
allow persons of ordinary skill in the art to recognize that the inventor invented what is claimed."
Ariad, 598 F .3d at 1351 (internal brackets and quotation marks omitted). "[T]he test for
sufficiency is whether the disclosure of the application relied upon reasonably conveys to those
skilled in the art that the inventor had possession of the claimed subject matter as of the filing
date." Id. "[T]he hallmark of written description is disclosure. Thus, 'possession as shown in
the disclosure' is a more complete formulation" of the written description requirement. Id.
"[T]he test requires an objective inquiry into the four comers of the specification [*8] from the
perspective of a person of ordinary skill in the art." Id. "[T]he written description requirement
does not demand either examples or an actual reduction to practice; a constructive reduction to
practice that in a definite way identifies the claimed invention can satisfy the written description
requirement." Id. at 1352. However, "a description that merely renders the invention obvious
does not satisfy the requirement." Id.

(...)

Defendants seek summary judgment that the '180 patent lacks adequate written
description for the functional limitations of claim 1: "( 1) the labeled polynucleotide is hybridized
to a nucleic acid sequence of interest, and (2) ... the label is detectable when the labeled
polynucleotide is so hybridized." (D.1. 228 at 6) In Defendants' view, the specification does not
adequately describe these limitations because Example V - which, according to Defendants, is
"the only example anywhere in the intrinsic record that purports to describe the manufacture or
synthesis of a phosphate labeled polynucleotide" - "undisputed[ly] ... provides [no] description
relating to hybridization or detectability upon hybridization." (Id. at 7) Defendants further
contend that Enzo's technical expert admitted that the rest of the specification contains "no
example, experiment, or data ... to suggest that the product of Example V could hybridize or
that its label is detectable when hybridized." (Id. at 11; see also D.I. 229-1 Ex. 5 at 131-32)
Enzo responds that "[a] person of ordinary skill [('POSA')] would have understood" the
words "probe" and "hybridization probe" in the '180 patent specification "to (1) be capable of
hybridizing and (2) be detectable upon hybridization." [*11] (D.I. 251 at 4) In Enzo's view, a POSA
would have also understood that "hybridization and detection is the plain purpose to which
Example Vis directed." (Id. at 9) In addition to Example V, Enzo argues that the specification's
"explicit disclosures of phosphate attachment[s], labels, linkages, and exemplary chemistry for
making the labeled nucleic acids ... would have served as common structural features that
allowed [POSAs] to recognize that the inventors possessed phosphate-labeled polynucleotides
capable of hybridization and subsequent detection." (Id. at 10)

(...)
The record demonstrates genuine disputes of material fact with respect to whether the
'180 patent contains adequate written description to support the functional limitations of claim 1.

Of enablement:

Defendants Gen-Probe and Hologic (collectively, hereinafter, "Hologic")5 request that the
Court grant summary judgment that the '180 patent is invalid for nonenablement because the
specification lacks any "meaningful disclosure ... on how to make and use the vast number of
phosphate-labeled polynucleotides covered by the asserted claims." (D.I. 222 at 7) In support of
its argument, Hologic points to the following statement in the '180 patent about a phosphate-
modified nucleotide:
The special nucleotides of this invention include a phosphoric acid P moiety (also designated hereinbelow as "PM"), a sugar or monosaccharide S moiety (also designated hereinbelow as "SM"), a base B moiety (also designated hereinbelow as "BASE"), a purine or a pyrimidine and a signal[]ing chemical moiety Sig covalently attached thereto, e[it]her to the P, Sor B moiety.
(D .I. 222 at 7) (quoting '180 patent at col. 48 11. 60-66)
[*16] Hologic argues that "[t]he above disclosure does not indicate ... any specific nucleotide,
any specific label, any specific linker, any specific position of a phosphate-modified nucleotide
within the polynucleotide, or any specific sequence of length of the polynucleotide."

(...)

While Enzo asserts that "the missing information could be found within the knowledge of a skilled artisan," Hologic replies that "the specification ... must supply the novel aspects of an
invention in order to constitute adequate enablement." (Id. at 5) (internal quotation marks
omitted) Moreover, even taking into account what a POSA knew at the pertinent time, that still
"fails to show any actual example of internal phosphate labeling by any method prior to June
13 1982." (Id. at 3)

The bottom line on enablement:

Based on the record, a reasonable factfinder could only find:
( 1) the quantity of experimentation necessary to arrive at embodiments equal to the full scope of the claims is undue;
(2) insufficient direction or guidance is presented in the patent to allow a POSA to avoid
undue experimentation;
(3) insufficient working examples are present; 8
(4) the invention arises in
a field of art that was highly unpredictable at the time of the invention;
(5) the prior art showed
that the pertinent field was unpredictable;
( 6) even though the relative skill of those in the art was
high, POSAs at the time did not have sufficient knowledge to "fill in" all that is missing from the
patent;
(7) the art was, as already noted, highly unpredictable; and
(8) the claims are extremely
broad. (See D.I. 223-1 Ex. 1iii!503-33)

The judge reviewed the arguments of Enzo:

Enzo opposes this conclusion, arguing that "chemistries ... known in the art at the
relevant time ... could have been used to create a polynucleotide" that meets claim 1's
limitations. (D.I. 247 at 14) Enzo's argument, however, "ignore[s] the essence of the
enablement requirement." Genentech, 108 F.3d at 1366. "It is the specification, not the
knowledge of one skilled in the art, that must supply the novel aspects of an invention in order to
constitute adequate enablement." Id. "[W]hen there is no disclosure of any specific starting
material or of any of the conditions under which a process can be carried out, undue
experimentation is required." Id. Thus, Enzo' s references as to what "wa[ s] known in the art"
(D.I. 247 at 14) are unavailing; "a failure to meet the enablement requirement ... cannot be
rectified by asserting that all the disclosure related to the process is within the skill of the art,"
Genentech, 108 F.3d at 1366.9

Accordingly, the Court will grant Hologic's motion for summary judgment that the '180
patent is invalid for nonenablement.

Footnote 8 is of interest:

Enzo admitted during prosecution of the '180 patent that Example V is a '"paper,' rather than 'working example[] .... "' (D.I. 223-3 Ex. 17 at ENZ0-0096256) In this litigation, Enzo attempts to create a dispute of fact by pointing to testimony that one inventor has some recollection of Example V being performed "around '82, I don't remember that now." (D.1. 250 at A294) Even assuming a reasonable finder of fact could conclude, on this record, that some version of Example V was carried out by the inventors, the overall record remains one on which a reasonable finder of fact could only find that the claims are not enabled.

Separately -->

In a 2015 decision [2015 U.S. Dist. LEXIS 87515 ], D. Delaware performed claim construction, including

The patent specification identifies "non-porous" materials "such as glass, or alternatively, plastic, polystyrene, polyethylene, dextran, polypropylene, and like" and contrasts these with "[c]onventional porous materials, e.g., nitrocellulose filters." ('197 patent, col. 6 ll. 4-9; see also D.I. 201 at 3 ("Enzo's construction is grounded in the intrinsic evidence, which cites glass, plastic, and polystyrene as examples of non-porous materials — none of which permit the passage of fluid — and a filter as an example of a porous material — which does permit the passage of fluid.")) Beyond this, however, the specification provides little additional guidance as to the proper construction of "non-porous."
The prosecution history makes clear that "[t]he key to the invention was getting nucleic acids to reliably bind in hybridizable form to the surface of a non-porous material . . . " (D.I. 161-62 Ex. B-8 at ENZO-0019424) (emphasis in original) "As the nucleic acids form a monolayer, saturating the surface . . . the nucleic acids are favorably placed to take part in hybridization reactions. Interactions with the solutions phase are much faster, because molecules do not have to diffuse into and out of the pores." (Id. at ENZO-0019427) This history supports Defendants' contention that "non-porous" means "having no pores."

Enzo's alternative construction, adding "not full of minute holes," creates ambiguity. (See C.A. 12-106 D.I. 108 at 3) Under this construction, a glass plate with a single pore would not be considered porous (because it would not be "full" of pores), even thought it would allow fluid to travel into and out of the support. The Court also rejects Defendants' addition of "nooks and crannies," as this limitation is not required by any intrinsic evidence (including the prosecution history). (See D.I. 161-62 Ex. B-8 at ENZO-0019427 ("The uniformity of these non- porous solid supports, which stands in contrast to the nooks and crannies of porous supports in the prior art . . . ")) Lastly, Life Technologies' proposal would improperly read into the claim language a limitation based solely on the disclosed embodiments in the specification, a limitation that is not present in the claim itself.

HBR proposal: "a prelitigation review board "

From the Harvard Business Review: We suggest a prelitigation review board that would examine infringement claims up front and provide preliminary assessments of their merits. The low-cost and efficient initial review would follow the case through any further actions, strengthening high-merit cases and reducing the incentives for pursuing low-merit ones. Additionally, the majority of the review process costs would be borne by the plaintiff; this would neutralize the up-front cost advantages trolls currently have.

Wednesday, June 28, 2017

Patent Docs on Cleveland Clinic. Matter of cherry-picking.

Most people have had the experience of becoming lost and, having arrived at their destination, realizing that it was only one false turn that caused their confusion. For those with a physics background one can recall the feature of vector calculus that a small displacement at a first position can result in a large displacement at a later position further along the vector's path. Both these thoughts come unbidden when reading the Federal Circuit's decision on June 16th in Cleveland Clinic Foundation v. True Health Diagnostics LLC (where the one false turn was the Court's decision in Ariosa Diagnostics v. Sequenom and that initial "small nudge" can be found in the Supreme Court's Mayo Collaborative Services v. Prometheus Laboratories decision).

Within his text, the topic of cherry-picking arose:

Addressing the procedural issues, the panel held that considering (and granting) a motion to dismiss based on Fed. R. Civ. Proc. 12(b)(6) without claim construction was not error, nor was there error in considering certain claims to be representative. Curiously, the Court based its affirmance of the latter principle on substantive grounds, that it disagreed with Cleveland Clinic that other claims provided the requisite "inventive concept" that the representative claims did not. This basis does not address the underlying question, of whether generally a district court can cherry pick claims asserted by a plaintiff to find that the Mayo/Alice test is not satisfied, and while this conclusion may be the correct one, in this case affirming this procedural shortcut precludes future plaintiffs of the ability to overcome a Section 101 challenge based on there being at least one asserted claim that satisfies the test. Of course, the precedent regarding Cleveland Clinics' second challenge, that a district court can grant a motion to dismiss without claim construction, is as prevalent as it is mystifying, and the panel here relies upon some of it to affirm the procedural posture of the case (e.g., Genetic Techs. Ltd. v. Merial L.L.C., 818 F.3d 1369, 1373–74 (Fed. Cir. 2016).

From 833 F.3d 656 (CA6 2016)
For instance, various appellate briefs supporting the Secretary's position now characterize Metzger's report, which was included with the plaintiffs' complaint, as "junk science" and attack its alleged "cherry picking" of data. But the Secretary never submitted any contrary proof to the district court. She did not even request limited discovery until July 13, 2016, the day before the hearing on plaintiffs' motion for a preliminary injunction and over seven weeks after the motion was filed. By that point, the district court reasonably concluded that her request was not timely.

From 2016 U.S. App. LEXIS 5578

Zheng asserts that the BIA "ignored relevant sections of the country reports" and "abused its discretion by cherry-picking the record evidence." "We presume that [the agency] has taken into account all of the evidence before [it], unless the record compellingly suggests otherwise." Xiao Ji Chen v. U.S. Dep't of Justice, 471 F.3d 315, 336 n.17 (2d Cir. 2006).

From 786 F.3d 733 :

As Garcia characterizes it, "the main issue in this case involves the vicious frenzy against Ms. Garcia that the Film caused among certain radical elements of the Muslim community." We are sympathetic to her plight. Nonetheless, the claim against Google is grounded in copyright law, not privacy, emotional distress, or tort law, and Garcia seeks to impose speech restrictions under copyright laws meant to foster rather than repress free expression. Garcia's theory can be likened to "copyright cherry picking," which would enable any contributor from a costume designer down to an extra or best boy to claim copyright in random bits and pieces of a unitary motion picture without [**9] satisfying the requirements of the Copyright Act. Putting aside the rhetoric of Hollywood hijinks and the dissent's [***1609] dramatics, this case must be decided on the law.

Tuesday, June 27, 2017

Stanford wins appeal at CAFC in interference case

The outcome:

The Board of Trustees of the Leland Stanford Junior
University (“Stanford”) appeals from orders of the Patent
Trial and Appeal Board (“Board”) in three interference
proceedings between Stanford and the Chinese University
of Hong Kong (“CUHK”). In all of these proceedings, the
Board found that Stanford’s claims were unpatentable for
lack of written description. See Quake v. Lo, No. 105,920
(P.T.A.B. Apr. 7, 2014); Lo v. Quake, No. 105,923
(P.T.A.B. Apr. 7, 2014); Lo v. Quake, No. 105,924
(P.T.A.B. Apr. 7, 2014).1 Because we conclude that the
Board relied on improper evidence to support its key
findings and did not cite to other substantial evidence to
support its findings, we vacate the Board’s interference
decisions and remand for further proceedings.

Of written description:

Whether a patent claim satisfies the written description
requirement of 35 U.S.C. § 112, paragraph 1, depends
on whether the description “clearly allow[s] persons of
ordinary skill in the art to recognize that [the inventor]
invented what is claimed.” Vas-Cath Inc. v. Mahurkar,
935 F.2d 1555, 1562–63 (Fed. Cir. 1991) (internal quotation
marks omitted) (quoting In re Gosteli, 872 F.2d 1008,
1012 (Fed. Cir. 1989)).
[W]hatever the specific articulation, the test requires
an objective inquiry into the four corners of
the specification from the perspective of a person
of ordinary skill in the art. Based on that inquiry,
the specification must describe an invention understandable
to that skilled artisan and show that
the inventor actually invented the invention
claimed.
Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351
(Fed. Cir. 2010) (en banc).

(...)

For these reasons, we vacate the interference decisions
and remand for the Board to reconsider whether
Quake’s relevant patents and applications satisfy the
written description requirement. In re Nuvasive, Inc., 842
F.3d 1376, 1382 (Fed. Cir. 2016) (finding that the Board
must “make the necessary findings and have an adequate
‘evidentiary basis for its findings’” (quoting In re Lee, 277
F.3d 1338, 1344 (Fed. Cir. 2002)); Ariosa Diagnostics v.
Verinata Health, Inc., 805 F.3d 1359, 1365 (Fed. Cir.
2015) (“[W]e must not ourselves make factual and discretionary
determinations that are for the agency to make.”)
(citing In re Lee, 277 F.3d at 1342, Interstate Commerce
Comm’n v. Bhd. of Locomotive Eng’rs, 482 U.S. 270, 283
(1987), and Chenery, 332 U.S. at 196–97).

Monday, June 26, 2017

CAFC in Nantkwest: “[a]ll expenses of the proceedings” under § 145 includes the pro-rata share of the attorneys’ fees the USPTO incurred to defend applicant’s appeal.

The outcome Nantkwest v. Matal :

Nantkwest, Inc. appeals from a decision of the United
States District Court for the Eastern District of Virginia
granting-in-part and denying-in-part the United States
Patent and Trademark Office (“USPTO”) Director’s motion
for fees. In its order, the district court granted the
Director’s requested witness’ fees but denied the requested
attorneys’ fees. The Director appeals the court’s denial
of attorneys’ fees. We reverse.

Some history

Section 145 provides that an applicant dissatisfied
with the PTAB’s decision may appeal directly to the
United States District Court for the Eastern District of
Virginia in lieu of immediate appeal to this court. 35
U.S.C. § 145. The statute further provides that the applicant
must pay “[a]ll of the expenses of the proceeding,”
id., “regardless of the outcome,” Hyatt v. Kappos, 625 F.3d
1320, 1337 (Fed. Cir. 2010) (en banc), aff’d and remanded,
132 S. Ct. 1690 (2012). After prevailing at the district
court on the merits, the Director filed a motion to recover
$111,696.39 of the USPTO’s fees under the § 145 expense
provision. See J.A. 84 (seeking $78,592.50 in attorneys’
fees (including paralegal fees) and $33,103.89 in expert
fees).1

(...)

The district court concluded that the “[a]ll expenses” provision of the
statute was neither sufficiently specific nor explicit
enough for the authorization of attorneys’ fees under this
Rule. Id. On appeal, the Director argues that the district
court erred by excluding the USPTO’s attorneys’ fees
under § 145. We have jurisdiction under 28 U.S.C.
§ 1295(a)(4)(C).

The main issue in the case:

The principal issue on appeal is whether § 145’s “[a]ll
expenses of the proceedings” provision authorizes an
award of the USPTO’s attorneys’ fees under this section.

Justice Scalia might have enjoyed this case:

The definitions and explanations that standard legal
dictionaries and treatises provide for the term “expense”
support this conclusion. Wright & Miller on Federal
Practice and Procedure, for example, defines this term as
“includ[ing] all the expenditures actually made by a
litigant in connection with the action,” including “attorney’s
fees.” 10 Charles Alan Wright et al., Federal Practice
and Procedure § 2666 (3d ed. 1998). Similarly, Black’s
Law Dictionary defines “expenses” as “expenditure[s] of
money, time, labor, or resources to accomplish a result.”
Black’s Law Dictionary 698 (10th ed. 2014) (“Black’s”)
(emphasis added).

The dissent summarily dismisses these definitions,
declaring that “they are not contemporaneous with Congress’s
introduction of the word ‘expenses’ into the Patent
Act in 1839.” Dissenting Op. 14. Relying on Nineteenth
Century dictionaries instead, the dissent concludes that
“the words ‘expense,’ ‘cost,’ and ‘damage’ were considered
synonymous around the time of the 1839 Amendments.”5
Id. at 6. Not so. The Patent Act of 1836 specifically distinguished
among these three terms. Compare Act of July 4,
1836, ch. 357, 5 Stat. 117, § 9 (“[M]oneys received into the
Treasury under this act shall constitute a fund for the
payment of salaries of the officers and clerks herein
provided for, and all other expenses of the Patent Office.”
(emphasis added)), with id. § 14 (“[W]henever, in any
action for damages for making, using, or selling the thing
whereof the exclusive right is secured by any patent . . . ,
a verdict shall be rendered . . . , it shall be in the power of
the court to render judgment for any sum above the
amount found by such verdict as the actual damages
sustained . . . , not exceeding three times the amount
thereof, according to the circumstances of the case, with
costs.” (emphases added)). The historical statute that the
dissent relies on simply does not support its conclusion. If
anything, this statute lends support to the majority’s
position by expressly characterizing the salaries of
USPTO officers and clerks and as “expenses.” Id. § 9. The
Supreme Court has observed the distinction between
“expenses” and “costs” recently, providing an interpretation
that comports with the modern definitions that the
dissent disregards.

Note footnote 5:

The dissent’s position here not only lacks support
in the briefing, but also directly undermines the party’s
position it purports to advance. Specifically, in arguing
that § 145 does not include attorneys’ fees, Nantkwest
cited the same dictionary and definitions that the dissent
now concludes bear no relevance to the interpretation of
this statute.

The bottom line

Accordingly, we hold that “[a]ll expenses of the proceedings”
under § 145 includes the pro-rata share of the
attorneys’ fees the USPTO incurred to defend applicant’s
appeal. To conclude otherwise would conflict with Hyatt,
where we recognized the “heavy economic burden” that
§ 145 shifts onto applicants for electing this favorable
appellate path. Hyatt, 625 F.3d at 1337.

The dissent noted:

This presumption against fee
shifting in American litigation dates back more than 200
years to Arcambel v. Wiseman, 3 U.S. (3 Dall.) 306 (1796).
“[T]he law of the United States, but for a few wellrecognized
exceptions not present [here], has always been
that absent explicit congressional authorization, attorneys’
fees are not a recoverable cost of litigation.” Runyon
v. McCrary, 427 U.S. 160, 185 (1976) (footnote omitted).

AND

It is a fundamental principle of statutory interpretation
that, “[w]here Congress includes particular language
in one section of a statute but omits it in another section
of the same Act, it is generally presumed that Congress
acts intentionally and purposely in the disparate inclusion
or exclusion.” Russello v. United States, 464 U.S. 16,
23 (1983) (quoting United States v. Wong Kim Bo,
472 F.2d 720, 722 (5th Cir. 1972)).

AND

Finally, if § 145 were a fee-shifting statute, it would represent a
particularly unusual divergence from the American Rule because it obligates
even successful plain-tiffs to pay the PTO’s attorneys’ fees.
“[W]hen Congress has chosen to depart from the American rule by statute,
virtually every one of the more than 150 existing federal fee-shifting
provisions predicates fee awards on some success by the claimant.”
Ruckelshaus v. Sierra Club, 463 U.S. 680, 684 (1983); see also Baker Botts, 135 S. Ct. at 2164
(recognizing deviations from American Rule “tend to authorize
the award of ‘a reasonable attorney’s fee,’ ‘fees,’ or ‘litigation costs,’
and usually refer to a ‘prevailing party’ in the context of an adversarial ‘action.’”).
Nothing in § 145 confines the award of expenses to a prevailing party.
Instead, it requires the applicant to pay “[a]ll the expenses of the proceedings,”
which according to the majority means the applicant pays for the PTO’s attor-neys’
fees in every § 145 proceeding. In these atypical circumstances,
I think Congress’s intent to award the PTO attorneys’
fees in every case should have been more clear.
I cannot agree that Congress used the word “ex-penses”
to effect such an unusual departure from the American Rule—
a departure that would saddle even prevailing applicants with the PTO’s attorneys’ fees.
3

Which law school for the study of "intellectual property"?

A letter to Law Admissions Q&A at US News stated:

I completed a Master of Science in biotechnology this year, and I want to shift
into intellectual property law, hence I will be taking my LSAT this September and
applying to law schools for the fall 2018 term.

I've listed out a few of the questions I had regarding this: 1. Is it necessary for me to have
prior knowledge about law in order to apply, or is it okay that I am from a STEM background? 2.
What is, on average, the minimum GPA required by top law schools? 3. Should I apply to law schools
that have an overall higher ranking or those that are specifically known to be good for patent law? –Prospective Patent J.D.

Part of the answer included:

Pay attention to other resources, too. Some schools have an entire department devoted to the
study of issues with patents, copyrights, trademarks and trade secrets, such as
Texas A&M University's Center for Law and Intellectual Property. Clinical work and externship opportunities are also worth considering.

At the Center for Law and Intellectual Property (CLIP) at Texas A&M University School of Law,
we combine classroom time with hands-on experience to prepare our students to navigate
the complex legal issues surrounding patents, copyrights, trademarks and trade secrets.

Most recently, peer surveys conducted by U.S. News and World Report have
ranked Texas A&M ​7th among the top IP law programs in the United States.

The Atlantic on plagiarism: garden variety stuff?

Covering the Jay Solomon matter, the Atlantic wrote:

Journalism scandals are all too common: Reporters are as fallible as the practitioners of
any other profession, and because the press loves to cover itself, such stories receive great attention.But typically they’re of the garden variety—plagiarism, dishonesty, fabrication.

The story of Jay Solomon is in an entirely different league. Solomon, until Wednesday [21 June 2017]
The Wall Street Journal’s chief foreign-affairs correspondent, apparently considered
becoming involved in business deals with a source who has worked for the CIA—and in particular,
Solomon was asked to take a proposal for hundreds of millions of dollars to the government
of the United Arab Emirates, according to the Associated Press. He was offered a 10 percent
stake in Denx, a company owned by the Iranian-born mogul Farhad Azima, the AP reports,
though there’s no evidence Solomon ever took it.

Interplay of enablement with written description

As to written description, IPWatchdog contains the following:

The third description requirement is the written description requirement, which is also found in 35 U.S.C. §112(a).
The written description requirement is separate and distinct from the enablement requirement, although related in
important ways. The written description requirement serves a teaching function, as a “quid pro quo” in which the
public is given meaningful disclosure in exchange for being excluded from practicing the invention for a limited period of time.

Still confused as to what this means? If you are confused you are understanding well. To be sure, the definition of the written description requirement is quite elusive. For generations the written description requirement had been confined to making sure that what was originally filed in the patent application adequately defined the full parameters of the invention being claimed. Today, the written description requirement means much more, but the Federal Circuit has yet to be able to articulate the requirements in a truly easy to explain way.

Perhaps the key to understanding the difference between enablement and the written description requirement is
that you can bootstrap knowledge of one of skill in the art into your application for enablement purposes, but no such bootstrapping is allowable under the written description requirement. If you leave something out
it is not a part of your written description even if someone of skill in the art would understand that you left
something out. In this sense the written description requirement is a “four corners” requirement. What you include
in your patent application defines the possible extent of the exclusive rights you will obtain, nothing more.
Once it is known what is in the four corners of your patent application and, therefore, the invention that you
actually possess, the law then turns to the enablement question and asks whether one of skill in the art would know
how to make and use the invention. In this regard the written description requirement and the enablement requirement
are similar and directly related, yet separate requirements.

One recalls the recent CAFC case Storer v. Clark, which included text:

The Board agreed with Clark’s position, and held that
the S1 provisional’s description of the 2´-keto precursor, in
combination with the Matsuda reference, was insufficient
to enable and thereby to establish possession of the
2´F(down) methyl(up) compound of claim 1 before Clark’s
priority date. The Board stated, correctly, that for new
chemical compounds the specification must provide sufficient
guidance that undue experimentation is not required
to obtain the new compounds.

apart from Storer, 2017 U.S. App. LEXIS 10945 (June 21, 2017): The Board agreed with Clark's position, and held that the S1 provisional's description of the 2´-keto precursor, in combination with the Matsuda reference, was insufficient to enable and thereby to establish possession of the 2´F(down) methyl(up) compound of claim 1 before Clark's priority date. The Board stated, correctly, that for new chemical compounds the specification must provide sufficient guidance that undue experimentation is not required to obtain the new compounds. ,

Cisco v. Cirrex, 856 F.3d 997; 2017 U.S. App. LEXIS 8264; 122 U.S.P.Q.2D (BNA) 1595: "Substantial evidence supports the Board's finding of lack of written description support for the diverting element claims. Because we affirm the Board's finding of lack of written description support, we need not and do not reach the Board's alternate grounds for unpatentability of the diverting element claims."

Sunday, June 25, 2017

Invalidating patents at PTAB

An article by Rochelle Dreyfuss in SLATE included

Versata Software learned the difference between the PTAB and the courts the hard way. In court, it successfully enforced a patent
on software for determining prices. Later on, the PTAB revoked the claims that the court had just found valid.

which is a "logical" possibility, because the standard for invalidity is more
easily met at PTAB.

However, recall the Acorda / Ampyra situation, wherein patents that passed muster at PTAB
were invalidated by the District of Delaware court.

CBS Sunday Morning on 25 June 2017, noting the 10th anniversary of the iPhone

Jane Pauley introduced the stories for June 25, 2017, beginning with David Pogue on the 10th anniversary (of public availability) of the iPhone, and then to Susan Spencer on John McEnroe, Erin Moriarty on Dick Gregory and Seth Doane on Murano glass and Lee Cowan, and Cyndi Lauper.

The news was a landslide in Xinmo, China, oil spill/fire in Pakistan, the GOP healthcare plan and the opening of the Wilshire Grand Center in Los Angeles. A blurb on a Neopolitan Mastif winning the ugliest dog contest.

The cover story by David Pogue noted the 10th anniversary of the iPhone to the public coming up on June 29, 2017. There was a reunion of four technical writers (including Steven Levy and Pogue (then at the NY Times)) who were given iPhones to try before the public unveiling. There was discussion of the touchscreen feature being worked on in 2005. And no one supposedly knew "how big this could be." There was a question of whether or not Apple is sunsetting. And a statement/opinion on Jobs: I don't think he foresaw the hugeness [?]

See also the 29 June 2009 piece on WIRED: June 29, 2007: iPhone, You Phone, We All Wanna iPhone

Almanac: June 25, 1997. Date of death of Jacques Costeau.

The piece by Seth Doane on Murano glass included "There are no secrets anymore," suggesting glass was now all art. [Could this be said of the iPhone, which primarily borrowed known technology?] In 1291, glass blowing moved from Venice to Murano, to limit the consequences of fires from the glass kilns. From a current glass person with different ideas: I am not threatening anybody. I'm trying to bring glass to another step.
In the earlier days, glass technology was a state secret, and one could not leave Murano with the knowledge.

The piece on Dick Gregory pointed to the symbolic significance of Dick Gregory being allowed to sit on the couch next to Jack Paar.
"Turn me loose." 1989 piece on Gregory on "60 Minutes."

Thursday, June 22, 2017

Desired qualities for next director of the USPTO?

From a post at norningconsult about qualities in the next patent office director:

The next PTO director should have served as a senior executive at a company that engages in research and development, and for which building and managing a patent portfolio is a central part of its business model. Patents and commercialization must have occupied the lion’s share of this person’s time and energy.

National Review on Bob Dylan "copying"

From the National Review:

To use the word “plagiarism” to describe what Dylan does, then, seems incorrect, tarnished as the word is with allegations of theft and deceit. The intention, in Dylan’s case, could not be further from the truth. The works of others are not something he turns to in times of sloth-induced desperation to pass off as his own. Rather, they are wellsprings of invention and interpretation, works to pair with others to create something new and, in many cases a whole greater in quality than the sum of its parts.

Previously unpublished results of clinical trials of Lemtrada (alemtuzumab) appears to contain key information as to why many multiple sclerosis patients who use it [Lemtrada] develop other autoimmune diseases.

Researchers looked at the immune cell mix after Lemtrada depleted many of those cells. They discovered that certain B-cells repopulate the body earlier than key regulatory T-cells, leading to an imbalanced immune system that is prone to turn on itself.

Although the findings pertained specifically to Lemtrada, they suggest that naturally occurring immune cell imbalance could lead to autoimmune diseases, researchers said.

Results Alemtuzumab depleted CD4+ T cells by more than 95%, including regulatory cells (−80%) and CD8+ T cells (>80% depletion), which remained well below reference levels throughout the trials. However, although CD19+ B cells were initially also depleted (>85%), marked (180% increase) hyperrepopulation of immature B cells occurred with conversion to mature B cells over time. These lymphocyte kinetics were associated with rapid development of alemtuzumab-binding and -neutralizing antibodies and subsequent occurrence of secondary B-cell autoimmunity. Hyperrepopulation of B cells masked a marked, long-term depletion of CD19+ memory B cells that may underpin efficacy in MS.

Conclusions and Relevance Although blockade of memory T and B cells may limit MS, rapid CD19+ B-cell subset repopulation in the absence of effective T-cell regulation has implications for the safety and efficacy of alemtuzumab. Controlling B-cell proliferation until T-cell regulation recovers may limit secondary autoimmunity, which does not occur with other B-cell–depleting agents.

The multiple sclerosis news today website indicated that the data analyzed by the Queen Mary University people was obtained through a Freedom of Information request to the European Medicines Agency, thereby making this story relevant to intellectual property:

Researchers from Queen Mary University of London used a Freedom of Information request to the European Medicines Agency to obtain full results of the Phase 3 clinical trials of Lemtrada.

Scientists know that many people who take Lemtrada develop autoimmune diseases. Those who conducted the trials had presented some of the unpublished information at conferences, but had yet to submit studies involving those results to scientific journals.

“We were very surprised to find such important information on B-cell dynamics were only partially described and remained unpublished, even though they were observed and analysed several years ago following the pivotal Phase 3 trials,” Klaus Schmierer, the senior author of the study, said in a press release.

The second sentence of the press release [available at https://www.eurekalert.org/pub_releases/2017-06/qmuo-put061217.php ] noted "there is an almost 50% chance of secondary autoimmune diseases..."

Separately, an article in medpagetoday by Judy George begins:

In an analysis of previously unpublished phase III data, U.K. researchers reported a massive, rapid repopulation of a subset of B cells without effective T-cell regulation in patients with multiple sclerosis (MS) treated with alemtuzumab (Lemtrada), which might have created an environment for secondary autoimmune disease.

Examining lymphocyte reconstitution data from the pivotal Comparison of Alemtuzumab and Rebif Efficacy in Multiple Sclerosis I and II (CARE-MS I and II) studies, Klaus Schmierer, PhD, FRCP, of Queen Mary University of London, and colleagues found that alemtuzumab depleted CD4 T cells by more than 95%, including regulatory cells and CD8 T cells, which remained well below reference levels throughout the trials. Although the drug also initially depleted CD19 B cells by more than 85%, immature B cells increased by 180% and converted to mature B cells over time. These changes were associated with the rapid development of alemtuzumab-binding and alemtuzumab-neutralizing antibodies and subsequent secondary B-cell autoimmunity. This B-cell hyperpopulation masked a long-term depletion of CD19 memory B cells that may underpin the efficacy of alemtuzumab in MS, the researchers reported in JAMA Neurology.

Wednesday, June 21, 2017

CAFC affirms PTAB in Storer v. Clark

The CAFC affirmed the Board in the Storer case:

We conclude that substantial evidence supports the
Board’s finding that “a high amount of experimentation is
necessary to synthesize” the target compound. The record
before the Board showed sufficient variability and unpredictability
to support the Board’s conclusion that Storer’s
provisional application did not enable the interference
subject matter. The Board’s decision is affirmed.

The opinion, written by Judge Newman, involved a patent interference
in the pharma area:

This patent interference contest involves methods of
treating hepatitis C by administering compounds having
a specific chemical and stereochemical structure

Of note:

To establish priority, Storer relied on the disclosure in
the provisional specification from which priority was
claimed for conception and constructive reduction to
practice. In its joint decision on Clark’s motion to deny
Storer the benefit of the provisional application and on
Clark’s motion to invalidate Storer’s claims on the
grounds of lack of enablement and written description,1
the Patent Trial and Appeal Board (PTAB or “Board”)
held that Storer’s provisional application was not enabling
for the count of the interference, and on that ground
the PTAB entered judgment granting priority to Clark.2
Storer appeals that judgment and the underlying decision
on Clark’s motions.

We take note that Storer initially filed in the District
of Delaware, seeking review of the Board’s decision under
35 U.S.C. § 146. The district court dismissed the case,
Idenix Pharmaceuticals. LLC v. Gilead Pharmasset LLC,
2016 WL 6804915, at *1 (D. Del. Nov. 16, 2016), based on
this court’s ruling in Biogen MA, Inc. v. Japanese Foundation
for Cancer Research, 785 F.3d 648 (Fed. Cir. 2015),
that the America Invents Act eliminated the option of
district court review under Section 146 for interferences
declared after September 15, 2012. Although Storer says
that Biogen was incorrectly decided, that decision is
binding on this panel.

Of undue experimentation:

The Board agreed with Clark’s position, and held that
the S1 provisional’s description of the 2´-keto precursor, in
combination with the Matsuda reference, was insufficient
to enable and thereby to establish possession of the
2´F(down) methyl(up) compound of claim 1 before Clark’s
priority date. The Board stated, correctly, that for new
chemical compounds the specification must provide sufficient
guidance that undue experimentation is not required
to obtain the new compounds.

(...)

The boundary between a teaching sufficient to enable
a person of ordinary skill in the field, and the need for
undue experimentation, varies with the complexity of the
science. Knowledge of the prior art is presumed, as well
as skill in the field of the invention. The specification
need not recite textbook science, but it must be more than
an invitation for further research. Genentech, Inc. v. Novo
Nordisk A/S, 108 F.3d 1361, 1366 (Fed. Cir. 1997).
In Genentech the patentee argued that the prior art
taught a method that could be used to produce a claimed
human growth hormone product, compensating for lack of
detail in the specification. The patentee argued that it
did not need to include information in the prior art. This
court agreed, but stressed the need to assure enablement
of the novel aspects of the invention:
It is true . . . that a specification need not disclose
what is well known in the art. See, e.g., Hybritech
Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 1367,
1385 (Fed. Cir. 1986). However, . . . . [i]t is the
specification, not the knowledge of one skilled in
the art, that must supply the novel aspects of an
invention in order to constitute adequate enablement.
Genentech, 108 F.3d at 1366.
The Storer provisional specification does not describe
synthesis of the 2´F(down) target compounds.

(...)

On review, we conclude that substantial evidence
supports the Board’s findings that the synthetic schemes
in Storer’s provisional application do not teach or suggest
conversion of any precursor into the 2´F(down) structure,
and that the Matsuda synthesis of a corresponding 2´-
methyl (down), 2´-hydroxyl (up) structure does not enable
a person of ordinary skill to produce the target compounds
without undue experimentation.
Wands factor 7, the predictability or unpredictability
of the art, appears to be particularly relevant. Although
Storer states that this is predictable chemistry, and
therefore that detailed specific examples are not necessary,
the Board’s findings are in accord with the record.

Tuesday, June 20, 2017

“Personal jurisdiction is a question of law that we review
de novo.” Autogenomics, Inc. v. Oxford Gene Tech.
Ltd., 566 F.3d 1012, 1016 (Fed. Cir. 2009). We apply
Federal Circuit law when reviewing claims “intimately
involved with the substance of the patent laws” and the
law of the regional circuit when reviewing state law
claims. Elecs. for Imaging, Inc. v. Coyle, 340 F.3d 1344,
1348 (Fed. Cir. 2003). Where, as here, the district court
decided personal jurisdiction “based on affidavits and
other written materials in the absence of an evidentiary
hearing, a plaintiff need only to make a prima facie showing
that defendants are subject to personal jurisdiction.”
Avocent Huntsville Corp. v. Aten Int’l Co., 552 F.3d 1324,
1329 (Fed. Cir. 2008). We “accept the uncontroverted
allegations in the plaintiff’s complaint as true and resolve
any factual conflicts in the affidavits in the plaintiff’s
favor.” Id. To make a prima facie showing, we ask
“whether a forum state’s long-arm statute permits service
of process and whether assertion of personal jurisdiction
violates due process.” Autogenomics, 566 F.3d at 1017.
The Kansas Supreme Court has interpreted Kansas’ longarm
statute to extend jurisdiction to the fullest extent
allowed by due process. Merriman v. Crompton Corp.,
146 P.3d 162, 179 (Kan. 2006).
Pursuant to 28 U.S.C. § 1367(a), “it is well established—in
certain classes of cases—that, once a court has
original jurisdiction over some claims in the action, it may
exercise supplemental jurisdiction over additional claims
that are part of the same case or controversy.” Exxon
Mobil Corp. v. Allapattah Servs., Inc., 545 U.S. 546, 552
(2005). To exercise supplemental jurisdiction, the district
court “must first have original jurisdiction over at least
one claim in the action.” Id. at 554.

At district court:

Drawing all reasonable inferences in favor of
NexLearn, the district court held that NexLearn failed to
allege that Allen had sufficient contacts with Kansas to
permit the exercise of specific jurisdiction. It determined
the NDA and EULA Kansas choice-of-law and forumselection
provisions were not relevant for specific jurisdiction
over NexLearn’s patent infringement claim. It held
that because five of Allen’s six emails to NexLearn employees
were sent before the ’522 patent issued on August
5, 2014, NexLearn’s patent infringement claim could
not have arisen out of or related to these emails. It held
Allen’s sole post-issuance email, as well as its offer of a
free trial of ZebraZapps to a NexLearn employee, could
not form a basis for exercising jurisdiction because these
contacts were manufactured by NexLearn’s unilateral
acts. The NexLearn employees, it reasoned, received
Allen’s emails only because they subscribed to Allen’s
mass emailing list and received a free trial of ZebraZapps
only because of a purchase attempt. Regarding Allen’s
ZebraZapps website, the district court held the website
alone, absent evidence of an actual sale, was insufficient
to confer specific jurisdiction. It held neither Allen’s
single sale of an unaccused product to a Kansas resident
nor its general advertisement in a trade publication was
relevant to NexLearn’s patent infringement claim. Because
it held it lacked personal jurisdiction over
NexLearn’s patent infringement claim, and because
NexLearn did not assert breach of contract as an independent
basis for the district court’s subject matter jurisdiction,
the district court granted Allen’s motion to
dismiss.

Plaintiff-appellant Nexlearn argued:

NexLearn alleges that personal jurisdiction exists for
its patent infringement claim, the only claim over which it
asserts the district court possesses original jurisdiction. A
district court can exercise personal jurisdiction over an
out-of-state defendant pursuant to either general or
specific jurisdiction. Under general jurisdiction, a district
court can “hear any and all claims against [out-of-state
defendants] when their affiliations with the State are so
‘continuous and systematic’ as to render them essentially
at home in the forum State.” Daimler AG v. Bauman, 134
S. Ct. 746, 749 (2014) (citation omitted). Specific jurisdiction
instead “focuses on the relationship among the defendant,
the forum, and the litigation.” Walden v. Fiore,
134 S. Ct. 1115, 1121 (2014) (alteration omitted). To
comport with due process, the out-of-state defendant must
have “minimum contacts” with the forum State “such that
the maintenance of the suit does not offend traditional
notions of fair play and substantial justice.” Int’l Shoe Co.
v. Washington, 326 U.S. 310, 316 (1945). At oral argument,
NexLearn stated it alleged both general and specific
jurisdiction. Oral arg. at 15:03–16:10. NexLearn did
not argue general jurisdiction in its briefing to us or below
to the district court. See NexLearn Br. 10; J.A. 7
(“NexLearn does not allege general jurisdiction but rather
that Allen had minimum contacts with Kansas based on
specific jurisdiction.”). We thus decline to address general
jurisdiction.

The CAFC stated:

We agree with the district court’s determination that
Allen’s contacts predating the issuance of the ’522 patent
are not relevant contacts for establishing specific jurisdiction
over NexLearn’s patent infringement claim.

As to a website:

Allen’s website together with its contacts with
NexLearn create only an “attenuated affiliation” with
Kansas as opposed to a “substantial connection” with the
forum State as required for specific jurisdiction. See
Burger King, 471 U.S. at 475. We thus affirm the district
court’s dismissal of NexLearn’s patent infringement claim
for lack of personal jurisdiction.

Of the supplemental (contract) claims:

While neither party
disputes that a claim for patent infringement falls within
the district court’s subject matter jurisdiction pursuant to
28 U.S.C. §§ 1331, 1338(a), the district court’s dismissal of
that claim for lack of personal jurisdiction left no remaining
claim over which the district court could exercise
original subject matter jurisdiction. See J.A. 17. A district
court cannot exercise supplemental jurisdiction over
a claim where original subject matter jurisdiction does not
exist. 28 U.S.C. § 1367(a). Because we affirm the district
court’s dismissal of NexLearn’s patent infringement claim
for lack of personal jurisdiction, we affirm the district
court’s dismissal of NexLearn’s supplemental claim for
breach of contract.

Monday, June 19, 2017

Copyright issue with Turnitin?

Turnitin isn’t selling teachers and administrators a product. The marketing on their website frames the Turnitin brand less as software and more as a pedagogical lifestyle brand. In fact, the word “plagiarism” is used only twice on their home page, in spite of the fact that the tool is first and foremost a plagiarism detection service. The rest of the copy and images are smoke and mirrors. They are “your partner in education with integrity.” They are “trusted by 15,000 institutions and 30 million students.” (We feel certain they didn’t ask those 30 million students whether they “trust” Turnitin.) The “products” most prominently featured are their “revision assistant” and “feedback studio.” For the teachers and administrators using Turnitin as a plagiarism detector, these features function like carbon offsetting. When asked whether their institution uses Turnitin, they can point to all the other things Turnitin can be used for — all the other things that Turnitin is not really used for. The site even attempts to hide its core functionality behind a smokescreen; in the description for the “feedback studio,” plagiarism detection is called “similarity checking.”

BUT, Turnitiin ONLY looks for similarity. It is not checking for copying without attribution (plagiarism). In the essay, Morris/Stommel talk about intellectual property (e.g., a “product,” some of which, like Turnitin, are designed to eat our intellectual property] but the word copyright arises only in statements from turnitin.
One puzzles at what Morris/Stommel mean in the text: Even if it is true that Turnitin doesn’t assert ownership over the intellectual property it collects, their statement is misleading. They are basically saying our brand is your brand — that by helping them build their business we all simultaneously protect our own intellectual property. This is absurd.

IPBiz suggests that Turnitin is NOT saying "our brand is your brand." They are saying, by showing similarities of your presented work to past work, Turnitin enables you to weed out weak parts and strengthen your work. Turnitin is not using past student work for its original purpose (in contrast to say, an essay mill).

This key point is ignored by Morris/Stommel in the text: In a recent conversation where he tried to explain why Turnitin’s violation of student intellectual property was a problem, Sean’s argument was countered with a question about whether that intellectual property was worth protecting. After all, most student work “isn’t worth publishing.” Ignoring for a moment this flagrant disregard for the value of student work, the point to make here is that Turnitin actively profits (to the tune of $752 million) from the work of students.

One knows from Feist that copyright requires only marginal creativity. The issue of "worth protecting" is not Turnitin's point. They are not using past student essays as essays and trying to compete with students in the marketplace. The essays stay in a vault. The past essays are comparators.

TimesHigherEd pushes the IP angle:

“Plagiarism detection software, like Turnitin, has seized control of student intellectual property,” write Mr Morris and Professor Stommel [in an essay in Hybrid Pedagogy]. “While students who use Turnitin are discouraged from copying other work, the company itself can strip-mine and sell student work for profit.”

Turnitin’s practices have been ruled as being fair use in a federal court, and the company itself offers a different perspective on its operations.

“When students engage in writing and submitting assignments via Turnitin’s solutions, students retain the copyright of the submitted papers,” said Chris Harrick, vice-president of marketing. “We never redistribute student papers, or reveal student information via the service.

(...)

But to Mr Morris and Professor Stommel, the ceding of control of students’ work to a corporation is a moral issue, even if it’s legally sound. Time spent on checking plagiarism reports is time that would be better spent teaching students how to become better writers in the first place, they argue.

“This is ethical, activist work….we must ask ourselves, when we’re choosing ed tech tools, who profits and from what?” they write in the essay. “Every essay students submit – representing hours, days or even years of work – becomes part of the Turnitin database, which is then sold to universities.”

In an interview, Dr Morris and Professor Stommel said that they wrote the post with a view to rethinking on a pedagogical level how students are taught about plagiarism, and what should be emphasised when teaching students how to write.

Sunday, June 18, 2017

CBS Sunday Morning on Fathers Day, June 18, 2017 does Monterey Pop and Custer's Last Stand

Jane Pauley introduced the stories for June 18, 2017, beginning with Ted Koppel's cover story on the increasing divide in American politics. Second mentioned was Anthony Mason on the 50th anniversary of Monterey Pop. Tony DeCappo on millenial dads, Mo Rocca on Custer's Las Stand, Seth Doane, Steve Hartman on the need to behave like a little leaguer, and DeMarco Morgan.

The news headlines were the USS Fitzgerald at Yokosuba, fires in Portugal, and the London fire. There was an image noting summer begins Wednesday, June 21, at 12:24 A.M. EDT.

Prior to the cover story, there were pieces by DeMarco Morgan on Cosby and Erin Moriarty on Michelle Carter (manslaughter because of texting).

The June 18 cover story ("The Great Divide") is related to a prior piece by Koppel, not mentioned by CBS on June 18. Within the prior March 2017 Koppel story ("The Great Divide") was text:

A Pew study finds 81% of voters say they cannot agree with the other side on basic facts, which may owe something to the president’s campaign against “fake news.”

CNN’s Jim Acosta: “Just because of the attack of fake news and attacking our network, I just want to ask you, sir …
President Trump: “I’m changing it from ‘fake news,’ though. ‘Very fake news.’”

There’s nothing new about simmering hostility between a President and the press.

There was a text from Fareed Zakaria [once accused of plagiarism; see 2012 Washington Post--Fareed Zakaria suspended by CNN, Time for plagiarism]: “I think the President is somewhat indifferent to things that are true or false. He has spent his whole life bullsh***ing. He has succeeded by bullsh***ng.”

Within the June 18, 2017 piece, Koppel spent some time with Yochai Benkler, who was referred to as an "honest academician." For clarity, Benkler is a Harvard Law grad (1994) and is a faculty co-director of the Berkman Klein Center for Internet & Society at Harvard. Whether law grads are academicians is open to question. Of relevance to intellectual property, Benkler in "Wealth of Networks" raises the possibility that a culture in which information is shared freely could prove more economically efficient than one in which innovation is encumbered by patent or copyright law. In the June 18 piece, it seemed that Benkler was saying that there was a uniformity in factual presentation by news groups (other than say by Breitbart). Pat Buchanan suggested that the great divide started with the November 1968 speech by Nixon on the silent majority and media followup thereto. Similarities between Buchanan's presidential run in 1992 and Trump's campaign were mentioned.

The Almanac piece was the creation of New Jersey's "Steel Pier" on June 19, 1898, which was attended by, among others, Annie Oakley. Yes, pictures of diving horses, and a 1938 color clip of The Three Stooges.

Next up, Daddy's home, featuring Millenial (born after 1980) fathers. A clip of a 1966 Lyndon Johnson establishing Fathers Day. Mention of the MGH "Fatherhood Project."

Seth Doane interviewed Lang Lang. Of note was a reference to classic music being the province only of professors (compare honest academicians)

Steve Hartman on the post (baseball) game handshake and how we should act more like little leaguers.

Anthony Mason on the 1967 Monterey Pop Festival, organized by John Phillips and Lou Adler. Top ticket: $6.50. Members of the governing group suggested musicians to appear. Michelle Phillips suggested Otis Redding. Paul McCartney suggested Jimi Hendrix. Competition between The Who and Hendrix. Eric Burdon there in 1967 and will be there in 2017.

The piece on Custer's Last Stand by Mo Rocca was poorly done. Presumably of news note because the "battle" was on June 25, 1876. There was mention of Custer's being "last in his class." There were two West Point Classes of 1861, one in May and one in June. Custer was indeed number 34 of 34 in June 1861. Number 1 in the class was Patrick H. O’Rorke, who was killed at Gettysburg. Number 11 was Alonzo Cushing, also killed at Gettysburg, and awarded the Medal of Honor. Number 33 (just ahead of Custer) was Frank A. Reynolds, who served in the Confederate Army. The Rocca piece mentioned economic troubles for Custer in 1876 but omitted his political troubles. Custer had to beg to be part of the expedition.
Also omitted was Custer's attack on an Indian encampment comprising mainly women and children, which provoked Custer's problems. Although there was reference to Custer's body being mutilated, Custer's was the only body of the command not scalped. No mention was made of Custer's brothers also killed at Big Horn, including the one awarded two Medals of Honor. LBE has previously noted an irony in Custer's work at East Cavalry Field (where his men were armed with repeating (Spencer) rifles) and at Little Big Horn (where only the Indians had repeating rifles)

Saturday, June 17, 2017

UWashington CoMotion innovation hub cutting 15% of staff

From a post at geekwire on the UWashington CoMotion innovation hub cutting 15% of staff:

A set of well-regarded licensed UW technologies (the Hall patents) generated immense societal and economic value and funded the Washington Research Foundation which has been a great asset to our state. As a symptom of an outmoded tech transfer business model, CoMotion expectedly hit a revenue cliff from the expiration of the Hall patents. These “black swan” events need environments to come to fruition while having a realistic business model for sustainability. The layoff decisions were not determined by performance and were necessitated by budget cuts at CoMotion.

If, as is obviously true, the expiration of the Hall patents was expected, the is obviously not a black swan event. Wikipedia notes of "black swan": The black swan theory or theory of black swan events is a metaphor that describes an event that comes as a surprise, has a major effect, and is often inappropriately rationalized after the fact with the benefit of hindsight.

Dylan/Nobel: "borrowings" as "daring and original signatures" ?

Of relevance to intellectual property are some comments made in Dylan/Nobel episode.

From the Weekly Standard:

Andrews also quotes a University of Minnesota music professor, who told the Minneapolis Star Tribune: "His [Nobel] lecture is wild and strange. It's meant to be a post-modern work of art. Any kind of a collage technique is fair game."

It's an argument as old as Dylan's plagiarism: the song-writer is a magpie, gathering influences and material from sources far and wide and making them his own through the magic of his genius. There's merit to the argument, if it's taken as a commonplace: All creative activity owes something to the creative activity of others. No less a personage than the former president of the Poetry Foundation once told Warmuth that Dylan's "borrowings" are "among the most daring and original signatures of his art." But you got to hit a limit somewhere. And I think you hit it when the act of claiming someone else's work as your own is called "original."

The classic formulation of the pro-Dylan argument was produced more than 15 years ago, during another Dylan plagiarism scandal, by a music critic for the New York Times: "The hoopla over [Dylan's plagiarism] is a symptom of a growing misunderstanding about culture's ownership and evolution, a misunderstanding that has accelerated as humanity's oral tradition migrates to the Internet. Ideas aren't meant to be carved in stone and left inviolate; they're meant to stimulate the next idea and the next."

Though wrong about everything else, this Times writer was right on the money when he mentioned the subject of "ownership." It is the nub of the matter. When Dylan takes other people's stuff for his own work, he doesn't just pass it along so that others in the "folk tradition" can then take it and claim it for their own, as part of the long glorious evolution of culture. No, he copyrights it. He makes people who want to use it pay for it. And he's got a nice big house in Malibu to prove it.

Paragraph 2: The invention is in the field of compositions for neuroprotection, particularly compositions that promote and protect neural cells in the central nervous system of a mammal such as a human. Also described are methods for repairing tissues of the central nervous system of a mammal such as a human. Neurodegenerative diseases represent the largest area of unmet clinical need in the Western world. They are characterised by a progressive loss of the structure or function of neurons in the nervous system (neurodegeneration) and include Alzheimer's Disease (AD), Parkinson's Disease (PD) and a host of other rarer conditions such as Huntington's Disease (HD), Frontotemporal dementia (FTD) and Amyotrophic Lateral Sclerosis (ALS). The process of neurodegeneration is not well understood and so the diseases that stem from it have no effective cures, nor is it possible to slow down their progression, as yet.

Paragraph 90: In the CNS, LIF is thought to act predominantly as an injury factor, optimising the pool of neural precursors available for repopulation during repair (Pitman et al 2004, Mol Cell Neuroscience). LIF promotes neural stem cell self-renewal in the adult brain, regulating the emergence of more differentiated cell types, which ultimately leads to an expansion of the neural stem cell pool (Bauer, S. et al., 2006). LIF also stimulates the proliferation of parenchymal glial progenitors, in particular oligodendrocyte progenitor cells, through the activation of gp130 receptor signaling within these cells. This effect of LIF can be used to enhance the generation of oligodendrocytes and suggests that LIF has both reparative and protective activities that makes it a suitable candidate for the treatment of CNS demyelinating disorders and injuries (Deverman, B. E. et al., 2012). Furthermore, LIF has been shown to directly prevent oligodendrocyte death in animal models of multiple sclerosis, which is a disabling inflammatory demyelinating disease of the CNS, and this effect complements endogenous LIF receptor signalling, which already serves to limit oligodendrocyte loss during immune attack (Butzkueven, H. et al., 2002). LIF has also been shown to up-regulate the re-expression of NPCs in the brain of a Parkinson's Disease mouse model (Liu, J. et al., 2009).

Paragraph 102: The link between IL6, a potent inducer of pathogenic inflammatory TH17 lymphocytes and neurodegenerative disease progression is of further relevance, since the inventors have found that LIF directly suppresses both IL6 activity and TH17 cell development and instead promotes tolerogenic T.sub.reg cells (Gao et al 2009; Park et al 2011). This correlates with the recent finding that T.sub.reg opposes TH17-driven dopaminergic neurodegeneration in a mouse model of Parkinson's Disease (Reynolds et al 2010); and that LIF opposes pathogenic TH17 cells in an experimental allergic encephalitis (EAE) model of multiple sclerosis, a demyelinating disease of the CNS (Cao et al 2011).

Also of relevance to multiple sclerosis, note published US application 20150366994, titled IMMUNO-MODULATORY COMPOSITION , first inventor Susan Metcalfe.

Paragraph 34:

The compositions of the invention are suitable for the treatment of autoimmune disorders. Local parenteral or subcutaneous delivery of the nanoparticle-comprising compositions of the invention into or around an inflamed joint can assist in amelioration of the symptoms of rheumatoid arthritis. Also, topical administration of an appropriate nanoparticle composition (i.e. as a lotion or skin cream) can be effective in treatment psoriasis. Finally, the nanoparticles can be incorporated into a time release depot formulation for longer term use, suitable for treatment of auto-immune encephalopathies and multiple sclerosis.

The first claim:

A composition for promoting an immune tolerance response in a mammal comprising: a) a pharmaceutically acceptable carrier solution; and b) a plurality of biodegradable polylactidecoglycolide (PLG) polymer nanoparticles, and wherein the PLG nanoparticles further comprise: (i) leukaemia inhibitory factor (LIF), wherein the LIF is encapsulated by the PLG nanaoparticle; and (ii) the PLG nanoparticles comprise an outer surface, wherein a targeting moiety that is able to bind selectively to an antigen present on the surface of a T lymphocyte cell is linked to the outer surface of the PLG nanoparticles.

Cleveland Clinic Foundation "Ariosa'd" by CAFC

The Cleveland Clinic Foundation lost:

The Cleveland Clinic Foundation and Cleveland
Heartlab, Inc. accused True Health Diagnostics LLC of
infringement of three patents that claim methods for
testing for myeloperoxidase in a bodily sample and a
fourth patent that claims a method for treating a patient
that has cardiovascular disease. The United States
District Court for the Northern District of Ohio found that
the asserted claims of the three testing patents are not
directed to patent-eligible subject matter and that Cleveland
Clinic failed to state a claim of contributory or induced
infringement of the fourth patent. For the reasons
explained below, we affirm.

The background

In 2003, researchers at the Cleveland Clinic Foundation
developed methods for detecting the risk of cardiovascular
disease in a patient. When an artery is damaged
or inflamed, the body releases the enzyme myeloperoxidase,
or MPO, in response. MPO is an early symptom of
cardiovascular disease, and it can thus serve as an indicator
of a patient’s risk of cardiovascular disease.
The prior art taught that MPO could be detected in an
atherosclerotic plaque or lesion that required a surgically
invasive method. Another prior art method indirectly
detected for MPO in blood. Yet another known method
could detect MPO in blood but yielded results that were
not predictive of cardiovascular disease. The inventors
here purportedly discovered how to “see” MPO in blood
and correlate that to the risk of cardiovascular disease.

To determine whether a claim is invalid under § 101,
we employ the two-step Alice framework. In step one, we
ask whether the claims are directed to ineligible subject
matter, such as a law of nature. Alice, 134 S. Ct. at 2355;
Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566
U.S. 66, 75–77 (2012), McRO, 837 F.3d at 1311–12; Ariosa
Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, 1375
(Fed. Cir. 2015). While method claims are generally
eligible subject matter, method claims that are directed
only to natural phenomena are directed to ineligible
subject matter. Ariosa, 788 F.3d at 1376. If the claims
are directed to eligible subject matter, the inquiry ends.
Thales Visionix Inc. v. United States, 850 F.3d 1343, 1349
(Fed. Cir. 2017).
The claims of the testing patents are directed to
multistep methods for observing the law of nature that
MPO correlates to cardiovascular disease.

(...)
This case is similar to our decision in Ariosa. In Ariosa,
the ineligible claims were directed to a method of
detecting paternally inherited cell-free fetal DNA, which
is naturally occurring in maternal blood. 788 F.3d at
1376. The inventors there did not create or alter any of
the genetic information encoded in that DNA. Id. Likewise,
here, the testing patents purport to detect MPO and
other MPO-related products, which are naturally occurring
in bodily samples. The method then employs the
natural relationship between those MPO values and
predetermined or control values to predict a patient’s risk
of developing or having cardiovascular disease. Thus, just
like Ariosa, the method starts and ends with naturally
occurring phenomena with no meaningful non-routine
steps in between—the presence of MPO in a bodily sample
is correlated to its relationship to cardiovascular disease.
The claims are therefore directed to a natural law.

Friday, June 16, 2017

CAFC discusses motivation to combine; copying from a party's brief in Outdry

The appellant Outdry lost at the CAFC:

Outdry Technologies Corp. (“Outdry”) appeals from
the Patent Trial and Appeal Board’s (“Board”) inter
partes review decision holding that claims 1–15 of U.S.
Patent No. 6,855,171 (“the ’171 patent,” directed to
methods of waterproofing leather) would have been
obvious over a combination of prior art. For the reasons
discussed below, we affirm.

Outdry also argues that the “process for waterproofing
leather” limitation is not disclosed in Thornton. This
language is in the preamble of the claim. And like most
preambles is simply a statement of intended use, not a
separate claim limitation. See Boehringer Ingelheim
Vetmedica, Inc. v. Schering-Plough Corp., 320 F.3d 1339,
1345 (Fed. Cir. 2003) (“[A] preamble simply stating the
intended use or purpose of the invention will usually not
limit the scope of the claim, unless the preamble provides
antecedents for ensuing claim terms and limits the claim
accordingly.”). Satisfaction of the claimed steps necessarily
results in satisfying a “process for waterproofing leather.”
This is not a separate limitation that must be
disclosed in Thornton in order to uphold the Board’s
obviousness determination.

Of motivation:

Outdry argues the Board failed to adequately articulate
why a person of ordinary skill in the art would have
been motivated to combine Thornton’s process with Scott
and Hayton’s disclosure of the density and size of the glue
dots.

(...)

The Board’s motivation to combine finding is reviewed
for substantial evidence. Belden, 805 F.3d at 1073. The
Board must support its finding that there would have
been a motivation to combine with a reasoned explanation
to enable our review for substantial evidence. In re
NuVasive, Inc., 842 F.3d 1376, 1382 (Fed. Cir. 2016). This
necessitates that the Board “not only assure that the
requisite findings are made, based on evidence of record,
but must also explain the reasoning by which the findings
are deemed to support the agency’s conclusion.” In re Lee,
277 F.3d 1338, 1344 (Fed. Cir. 2002). Under this framework
“we will uphold a decision of less than ideal clarity if
the agency’s path may reasonably be discerned,” but “we
may not supply a reasoned basis for the agency’s action
that the agency itself has not given.” Bowman Transp.,
Inc. v. Ark.-Best Freight Sys., Inc., 419 U.S. 281, 285–86
(1974).
We have criticized the Board for failing to adequately
explain its findings. Missing from those Board decisions
were citations to evidence, reasoned explanations, or
explicit findings necessary for us to review for substantial
evidence.

For example, in Rovalma, we vacated the
Board’s obviousness decision where “the Board did not
cite any evidence, either in the asserted prior-art references
or elsewhere in the record, with sufficient specificity
for us to determine whether a person of ordinary skill in
the art would have been so motivated.” Rovalma, S.A. v.
Böhler-Edelstahl GmbH & Co. KG, 856 F.3d 1019, 1025–
26 (Fed. Cir. 2017). In Van Os, we held the Board’s
finding that it would have been intuitive to combine prior
art lacked the requisite reasoning because “[a]bsent some
articulated rationale, a finding that a combination of prior
art would have been ‘common sense’ or ‘intuitive’ is no
different than merely stating the combination ‘would have
been obvious.’” In re Van Os, 844 F.3d 1359, 1361 (Fed.
Cir. 2017); see also Arendi S.A.R.L. v. Apple Inc., 832 F.3d
1355, 1362 (Fed. Cir. 2016) (“[R]eferences to ‘common
sense’—whether to supply a motivation to combine or a
missing limitation—cannot be used as a wholesale substitute
for reasoned analysis and evidentiary support . . . .”);
Cutsforth, Inc. v. MotivePower, Inc., 636 F. App’x 575, 578
(Fed. Cir. 2016) (vacating the Board’s decision where the
Board summarized the parties’ arguments and rejected
the arguments of one party but did “not explain why it
accept[ed] the remaining arguments as its own analysis”).
In NuVasive, we vacated the Board’s decision because the
Board “never actually made an explanation-supported
finding” that a person of ordinary skill in the art would
have been motivated to combine the prior art. 842 F.3d
at 1384. In Icon Health, we held that the Board failed to
make requisite fact findings and provide an adequate
explanation to support its obviousness determination
where it merely agreed with arguments made in the
petitioner’s brief for which no evidence was cited. Icon
Health & Fitness, Inc. v. Strava, Inc., 849 F.3d 1034,
1042–48 (Fed. Cir. 2017) (holding that attorney argument
is not evidence and the Board’s adoption of petitioner’s
brief did not “transform [the petitioner’s] attorney argument
into factual findings or supply the requisite explanation
that must accompany such findings”).

[ BUT ]

The Board’s decision here does not suffer from similar
deficiencies. The Board clearly articulated Geox’s arguments
for why a person of ordinary skill in the art would
have been motivated to modify Thornton’s process of
adhering dots to create waterproof and breathable leather
with Hayton and Scott’s disclosed glue patterns.

The Board recited Geox’s argument that “the
discontinuous glue pattern is a matter of optimization as
taught by Scott, which teaches optimizing the amount of
glue necessary to provide sufficient adhesion to bond the
two layers while minimizing the area of blocked micropores.”

It explained Geox’s position that Scott and Hayton are from
the same field of endeavor and that both disclose fabrics
that are water impermeable and vapor permeable.

It recited Geox’s
argument for a motivation to combine based on this
evidence: “Scott provides a reason for optimizing the
amount of adhesive that Thornton and Hayton teach to
apply to a semi-permeable membrane, which is to provide
good adhesion while maintaining vapor permeability.”

It then expressly
adopted Geox’s rationale and found that this provided a
motivation to combine Thornton with Scott and Hayton.
The Board found that Geox “provided a rational underpinning
for combining the disclosures of Scott and Hayton,
which provide guidance for the density and size of
adhesive dots to adhere a semi-permeable membrane to a
porous layer.”

The Board engaged in reasoned
decisionmaking and sufficiently articulated its analysis in
its opinion to permit our review. It contains a clear and
thorough analysis.

The CAFC does not conceal that PTAB basically adopted the
position of a party.

In fact, the CAFC then stated:

The Board’s reliance on Geox’s arguments does not
undermine its otherwise adequate explanation for finding
a motivation to combine. The Board did not reject Outdry’s
positions without clarity as to why it found Geox’s
arguments persuasive. It did not incorporate Geox’s
petition by reference, leaving uncertainty as to which
positions the Board was adopting as its own. Nor is this a
situation where “a particular fact might be found somewhere
amidst the evidence submitted by the parties,
without attention being called to it,” such that it is unclear
what evidence the Board may or may not have relied
on to find a motivation to combine. See Rovalma, 856
F.3d at 1029. The Board is “permitted to credit a party’s
argument as part of its reasoned explanation of its factual
findings”; it simply must “explain why it accepts the
prevailing argument.” Icon, 849 F.3d at 1047 (alteration
omitted). In this case, the Board articulated Geox’s
arguments with evidentiary support and expressly adopted
them to find there would have been a motivation to
combine. The Board sufficiently explained why it found
that Geox’s arguments supported finding a motivation to
combine.

Also on motivation:

The Board was not required to limit its motivation to combine
inquiry to the problem faced by the inventor of the
’171 patent. The Supreme Court expressly rejected this
argument in KSR: “the problem motivating the patentee
may be only one of many addressed by the patent’s subject
matter.” KSR Int’l Co v. Teleflex Inc., 550 U.S. 398,
420 (2007). Outdry appears to interpret KSR’s use of the
phrase “addressed by the patent” to suggest the problem
must be identified within the patent. Neither KSR nor
our post-KSR precedent limits the motivation to combine
inquiry in this manner. See, e.g., Par Pharm., Inc. v. TWI
Pharm., Inc., 773 F.3d 1186, 1197 (Fed. Cir. 2014) (“Par’s
argument, however, ignores that we are not limited to the
same motivation that may have motivated the inventors.”);
Alcon Research, Ltd. v. Apotex Inc., 687 F.3d 1362,
1368 (Fed. Cir. 2012) (“We have repeatedly held that the
motivation to modify a prior art reference to arrive at the
claimed invention need not be the same motivation that
the patentee had.”). “The obviousness analysis cannot be
confined by a formalistic conception of the words teaching,
suggestion, and motivation, or by overemphasis on the
importance of published articles and the explicit content
of issued patents.” KSR, 550 U.S. at 419. Any motivation
to combine references, whether articulated in the references
themselves or supported by evidence of the
knowledge of a skilled artisan, is sufficient to combine
those references to arrive at the claimed process. The
motivation supported by the record and found by the
Board need not be the same motivation articulated in the
patent for making the claimed combination. The Board’s
fact finding regarding motivation to combine is supported
by substantial evidence. We see no error in the Board’s
conclusion that the claims would have been obvious to a
skilled artisan based on the facts presented.

***
A claim at issue

1. A process for waterproofing leather (1), comprising
directly pressing on an internal surface of
the leather (1) at least one semi-permeable membrane
(2) whose surface contacting the leather (1)
is provided with a discontinuous glue pattern to
adhere the leather to the semi-permeable membrane,
wherein the glue pattern is formed of a
multiplicity of dots having a density included between
50 dots/cm2 and 200 dots/cm2.

The Board found U.S. Patent No. 5,244,716
(“Thornton”) discloses all elements of claims 1 and 9
except the density of the dots (claim 1) and the sizes of the
dots (claim 9). Thornton is directed to “waterproof but
breathable articles of clothing” including stockings,
gloves, and hats.

For disclosure of the density and sizes of the dots, the
Board relied on “Coated and Laminated Fabrics” in
Chemistry of the Textiles Industry (“Scott”) and U.S.
Patent No. 6,139,929 (“Hayton”). Scott discloses adhering
a waterproof, vapor permeable membrane to fabric for
rainwear in which there is “sufficient adhesive to bond the
hydrophobic ‘non-stick’ film to a textile fabric, but the
adhesive dot coverage has to be kept low to minimize the
area of blocked micropores.”

***

"Motivation to combine" is reviewed for substantial evidence.

Of something to think about-->

In Bright v. Westmoreland County, 380 F.3d 729, 731 (CA3 2004), the Third Circuit stated:
Here, however, we are not dealing with findings of fact. Instead, we are confronted
with a District Court opinion that is essentially a verbatim copy of the appellees' proposed opinion.

(...)

Judicial opinions are the core work-product of judges. They are much more than findings of fact and
conclusions of law; they constitute the logical and analytical explanations of why a judge arrived
at a specific decision. They are tangible proof to the litigants that the judge actively wrestled
with their claims and arguments and made a scholarly decision based on his or her own reason and logic.
When a court adopts a party's proposed opinion as its own, the court vitiates the vital purposes served by judicial opinions.

****
Also from a 2011 post on the Volokh Conspiracy about Cojocaru v. British Columbia Women’s Hospital & Health Center —>

Rather, the problem, as the B.C. Court of Appeal panel majority understood it, is that a judge is supposed to “independently and impartially considered the law and the evidence and arrived at his own conclusions on the complex issues before him,” and simply adopting hundreds of paragraphs of a party’s papers casts doubt on that. It’s of course possible, as Prof. Poser suggests, that a judge may well consider the matter thoroughly but think one party’s analysis is precise enough. But the verbatim copying gives reason to doubt that, especially since a party’s analysis — even when generally sound — will almost always be framed in the way that’s most favorable to that party, and will thus very rarely be the way that a neutral arbiter would characterize the matter. (This is also an issue in plagiarism by students, where verbatim copying suggests that the student didn’t fully confront the issue; but that’s only a part of the objection to academic plagiarism.)

Volokh quoted Bill Poser: “Judges, unlike authors of fiction, are not paid to be original. If one party states the facts or the law clearly and accurately, by all means the court should make use of the work that party’s attorneys have already done rather than spending time rephrasing it.”

But, of course, it the facts and law relied upon by the copying judge are NOT accurate, the act of copying is especially pernicious.

Sadly, citations to the Cojocaru appellate decision are likely to fall on deaf ears.

About Me

I'm a patent lawyer located in central New Jersey. I have a J.D. from the University of Chicago and a Ph.D. from Stanford University, where I studied graphite intercalation compounds at the Center for Materials Research. I worked at Exxon Corporate Research in areas ranging from engine deposits through coal and petroleum to fullerenes. An article that I wrote in The Trademark Reporter, 1994, 84, 379-407 on color trademarks was cited by Supreme Court in Qualitex v. Jacobson, 514 US 159 (1995) and the methodology was adopted
in the Capri case in N.D. Ill. An article that I wrote on DNA profiling was cited by the Colorado Supreme Court (Shreck case) and a Florida appellate court (Brim case). I was interviewed by NHK-TV about the Jan-Hendrik Schon affair. I am developing ipABC, an entity that combines rigorous IP analytics with study of business models, to optimize utilization of intellectual property. I can be reached at C8AsF5 at yahoo.com.